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New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Chronic Hepatitis B Virus (HBV) infection affects nearly 300 million people worldwide and is a leading cause of liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). In France, it affects around 0.3% of the population. Current clinical practice relies on traditional biomarkers, such as HBV DNA and HBsAg, to monitor viral replication and disease progression. However, these biomarkers do not fully capture the viral activity or predict clinical outcomes. Recently, new biomarkers like HBcrAg and HBV RNA have emerged, showing promise for better understanding the natural history of the infection and guiding treatment decisions. The main objective of this research is to evaluate the predictive role of these biomarkers (HBcrAg, HBV RNA) in HBV-infected patients, focusing on their association with HBsAg seroconversion and their ability to predict clinical events like cirrhosis and HCC. Secondary objectives include describing the clinicobiological characteristics of patients, determining HBV genotypes, characterizing the impact of HBV on the host's transcriptome, and studying the biomarkers' role in different phases of the infection and treatment. The ultimate goal is to identify more accurate biomarkers to guide antiviral treatment, predict disease progression, and potentially determine when treatment can be safely discontinued.
Official title: New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
900
Start Date
2023-11-28
Completion Date
2038-11-27
Last Updated
2025-04-02
Healthy Volunteers
No
Interventions
Collection of blood samples for the study of HBV biomarkers
The intervention involves the additional and minimal collection of two blood samples during routine care procedures (9mL in a dry tube and 9mL in a Paxgene tube). These samples are specifically collected for research purposes and will be stored in the laboratory at the Henri Mondor Biobank Platform under the responsibility of Pr Bijan Ghaleh-Marzban for 15 years. The samples will be preserved under strict conditions and may be used for future analyses related to the pathology of HBV infection or other scientific advancements, with the patient's informed consent.
Locations (1)
Clinical Research Unit (CRU) Henri Mondor.
Créteil, Créteil, France